Walgreens Natural Yeast Treatment

Calendula, Melaleuca


Walgreens
Human Otc Drug
NDC 0363-6501
Walgreens Natural Yeast Treatment also known as Calendula, Melaleuca is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Walgreens Natural Yeast Treatment is 0363-6501. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Walgreens Natural Yeast Treatment drug includes Calendula Officinalis Flowering Top - 3 [hp_X]/14g Chamomile - 3 [hp_X]/14g Melaleuca Cajuputi Whole - 3 [hp_X]/14g Olive Oil - 3 [hp_X]/14g . The currest status of Walgreens Natural Yeast Treatment drug is Active.

Drug Information:

Drug NDC: 0363-6501
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Walgreens Natural Yeast Treatment
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Calendula, Melaleuca
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Walgreens
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CALENDULA OFFICINALIS FLOWERING TOP - 3 [hp_X]/14g
CHAMOMILE - 3 [hp_X]/14g
MELALEUCA CAJUPUTI WHOLE - 3 [hp_X]/14g
OLIVE OIL - 3 [hp_X]/14g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:VAGINAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 30 Dec, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:WALGREENS
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0311917030593
UPC stands for Universal Product Code.
NUI:N0000191261
M0012553
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:18E7415PXQ
FGL3685T2X
K62C66D9LN
6UYK2W1W1E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Lipid Emulsion [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:Lipids [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Lipid Emulsion [EPC]
Lipids [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0363-6501-2814.2 g in 1 TUBE, WITH APPLICATOR (0363-6501-28)29 Jan, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose healing agent anti-yeast anti-microbial and healing agent anti-itch and anti-inflammatory agent antimicrobial and healing agent

Product Elements:

Walgreens natural yeast treatment calendula, melaleuca peg-8 beeswax oatmeal melaleuca cajuputi whole melaleuca cajuputi whole chamomile chamomile olive oil olive oil lavender oil calendula officinalis flowering top calendula officinalis flowering top

Indications and Usage:

Uses treats vaginal yeast infections. relieves external; itching and irritation due to vaginal yeast infection.

Warnings:

Warnings for vaginal use only do not use if you never had a vaginal yeast infection diagnosed by a doctor this yeast treatment may damage condoms and diaphragms and cause them to fall. ask a doctor before use if you have vaginal itching abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, foul-smelling discharge. you may have a more serious condition. vaginal yeast infections often. been exposed to the hiv that cause aids are under 12 years of age when using this product do not use tampons, douches, spermicides, or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or stds do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur. stop use and ask a doctor if symptoms do not improve in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge if pregnant or breast-feeding ask a health professional before use keep o
ut of reach of children if swallowed, get medical help or contact a poisonocntrol center right away.

When Using:

When using this product do not use tampons, douches, spermicides, or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or stds do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur.

Dosage and Administration:

Directions before using this product, read the enclosed instructions for complete directions and information adults and children 12 years and over vaginal ointment: fill the applicator with vaginal oiutn=ment. lie down in bed. gently insert the filled applicator into the vagina. discard applicator after each use. remain lying down to avoid leakage. repeat on the second night, external itch relief ointment: squeeze a small amount of ointment onto your fingertip. apply the ointment onto the itchy skin outside the vagina. use as needed. children under 12 years: ask a doctor.

Stop Use:

Stop use and ask a doctor if symptoms do not improve in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge

Package Label Principal Display Panel:

Label label

Further Questions:

Questions call - 1800-925-4733


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.